PROVIGIL 200MG TABS 30S

Provigil (modafinil 200 mg) is a wakefulness-promoting agent used to improve alertness in patients with excessive daytime sleepiness associated with specific sleep disorders. 

Provigil (modafinil 200 mg) is approved for the treatment of excessive daytime sleepiness (EDS) associated with narcolepsy, obstructive sleep apnoea/hypopnoea syndrome (OSAS), as adjunct therapy where primary treatment (CPAP) is inadequate, and shift work sleep disorder (SWSD).

It does not treat the underlying cause of the sleep disorder.

Provigil tablets may be taken with or without food. The recommended dose is 200 mg once daily.

Narcolepsy and Obstructive Sleep Apnoea

•     200 mg orally once daily as a single morning dose.

•     Doses up to 400 mg/day have been studied and are generally well tolerated, but evidence for additional benefit over 200 mg is limited.

•     Do not use as a substitute for adequate treatment of OSAS (e.g., CPAP); modafinil is an adjunct to, not a replacement for, primary therapy.

Shift Work Sleep Disorder

•     200 mg orally taken approximately 1 hour before the start of the work shift.

Special Populations

•     Severe hepatic impairment: Reduce dose to 100 mg/day.

•     Elderly patients: Lower doses may be appropriate due to decreased renal and hepatic clearance.

•     Renal impairment: No dose adjustment generally required; caution in severe impairment.

•     Not approved for use in children or adolescents for sleep disorders.

Side effects vary in frequency and severity. Not every patient will experience all listed effects. Seek immediate medical attention for any serious or unexpected reactions.

•     Serious skin reactions: Rare but severe cutaneous reactions (SJS, TEN) have occurred. Discontinue at the first appearance of any rash and do not re-challenge.

•     Psychiatric events: Modafinil can precipitate mania, psychosis, or aggression in predisposed individuals. Use with extreme caution in patients with a history of psychosis, mania, or depression.

•     Contraception: Modafinil induces CYP3A4 and may significantly reduce the efficacy of hormonal contraceptives (oral, injectable, implant). Alternative or additional non-hormonal contraceptive methods are required during and for 2 months after stopping modafinil.

•     Cardiovascular monitoring: Blood pressure and heart rate should be monitored periodically. Avoid in patients with unstable cardiovascular conditions.

•     Dependence and misuse: While less problematic than classical stimulants, modafinil is a controlled substance due to its wake-promoting and potential mood-elevating effects. Monitor for signs of misuse.

The following interactions are clinically significant. Always inform your healthcare provider of ALL medicines, supplements, and herbal products you are taking.

•     Hormonal contraceptives (oral pills, implants, injections): Significantly reduced contraceptive efficacy due to CYP3A4 induction; use alternative methods.

•     Cyclosporine: Modafinil reduces cyclosporine levels; monitor cyclosporine blood levels and adjust dose accordingly.

•     CYP2C19 substrates (phenytoin, diazepam, omeprazole, warfarin, some antidepressants): Modafinil inhibits CYP2C19, potentially increasing plasma levels of these drugs.

•     MAO inhibitors: Use with caution; interaction potential with sympathomimetic activity.

•     Methylphenidate or amphetamines: No clinically significant pharmacokinetic interaction reported, but additive cardiac stimulation is possible.

•     Warfarin: Modafinil may increase warfarin levels through CYP2C19 inhibition; monitor INR.

Store below 25°C. Keep in original packaging, protected from moisture. Keep out of reach of children and persons other than the intended patient.

Modafinil is a Schedule IV controlled substance requiring controlled drug register documentation. Before dispensing, verify that the prescriber has documented an appropriate sleep disorder diagnosis. Counsel all female patients of childbearing potential on reduced hormonal contraceptive efficacy; this is a clinically important interaction often overlooked. Screen for concurrent CNS-active drugs, particularly those metabolised by CYP2C19 (warfarin, phenytoin, diazepam). Advise patients not to use Provigil for cognitive enhancement or fatigue not related to sleep disorders, this is off-label and potentially harmful.

Q1: What is Provigil used for?

A: Provigil is approved to treat excessive sleepiness caused by narcolepsy, obstructive sleep apnoea (where CPAP is not fully effective), and shift work sleep disorder. It promotes wakefulness without being a traditional stimulant.

Q2: Is Provigil like taking amphetamines or Ritalin?

A: Provigil has a different mechanism of action from traditional stimulants. It is less likely to cause the jitteriness, cardiovascular stimulation, or rebound "crash" typical of amphetamines. However, it is still a controlled substance because of its potential for non-medical use.

Q3: Can I take Provigil every day indefinitely?

A: Provigil is intended for long-term management of chronic conditions like narcolepsy when prescribed and supervised by a doctor. However, tolerance to its effects can develop. Regular reassessment is recommended to confirm ongoing benefit and necessity.

Q4: Will Provigil work if I have just had a poor night's sleep?

A: Modafinil is not intended to compensate for acute sleep deprivation in healthy individuals. It is for patients with specific medical sleep disorders. Using it to push through a single bad night can disrupt normal sleep patterns.

Q5: Why might it interfere with my contraceptive pill?

A: Modafinil increases the activity of a liver enzyme (CYP3A4) that breaks down the hormones in the pill. This can lower hormone levels enough to reduce contraceptive effectiveness. Use a reliable non-hormonal method (e.g., condoms) during treatment and for 2 months after stopping.